Treatment Use Study With Sunitinib (SU011248) For Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma

This treatment has been approved for sale to the public.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00130897
First received: August 14, 2005
Last updated: March 8, 2012
Last verified: March 2012
  Purpose

The primary objective of this protocol is to provide access to SU011248 treatment for patients with metastatic RCC who are ineligible for participation in ongoing SU011248 clinical studies and have the potential to derive clinical benefit from treatment with SU011248 based on the judgment of the investigator.


Condition Intervention
Carcinoma, Renal Cell
Drug: Sutent

Study Type: Expanded Access     What is Expanded Access?
Official Title: A SU011248 Expanded Access Protocol For Systemic Therapy Of Patients With Metastatic Renal Cell Carcinoma Who Are Ineligible For Participation In Other SU011248 Protocols But May Derive Benefit From Treatment With SU011248

Resource links provided by NLM:


Further study details as provided by Pfizer:

Study Start Date: July 2005
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Sutent
    Sutent, 25, 37.5. or 50 mg daily
Detailed Description:

Given that an Expanded Access study does not meet the definition of a controlled clinical investigation, and as such, is not considered an applicable drug clinical trial per NIH, Basic Results for such studies are not required to be reported. Protocol A6181037 has been identified as an Expanded Access trial, and has been registered to ClinicalTrials.gov, however Basic Results will not be posted.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • renal cell carcinoma that is not amendable to standard therapy with curative intent

Exclusion Criteria:

  • current treatment in another therapeutic clinical trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00130897

  Hide Study Locations
Locations
United States, Arizona
Pfizer Investigational Site
Scottsdale, Arizona, United States, 85260
United States, California
Pfizer Investigational Site
San Francisco, California, United States, 94115-2378
Pfizer Investigational Site
San Francisco, California, United States, 94115
United States, Colorado
Pfizer Investigational Site
Aurora, Colorado, United States, 80040-0510
United States, Connecticut
Pfizer Investigational Site
Norwalk, Connecticut, United States, 06856
United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 33176
Pfizer Investigational Site
Ocala, Florida, United States, 34474
Pfizer Investigational Site
Tampa, Florida, United States, 33612
United States, Georgia
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Atlanta, Georgia, United States, 30309
United States, Illinois
Pfizer Investigational Site
Maywood, Illinois, United States, 60153
United States, Indiana
Pfizer Investigational Site
Indianapolis, Indiana, United States, 46260-2082
United States, Iowa
Pfizer Investigational Site
Council Bluffs, Iowa, United States, 51503
United States, Louisiana
Pfizer Investigational Site
Covington, Louisiana, United States, 70433
Pfizer Investigational Site
Gretna, Louisiana, United States, 70056
Pfizer Investigational Site
Marrero, Louisiana, United States, 70072
Pfizer Investigational Site
Metairie, Louisiana, United States, 70006
Pfizer Investigational Site
Metairie, Louisiana, United States, 70002
Pfizer Investigational Site
New Orleans, Louisiana, United States, 70115
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
Pfizer Investigational Site
Boston, Massachusetts, United States, 02115
Pfizer Investigational Site
Boston, Massachusetts, United States, 02215
United States, Michigan
Pfizer Investigational Site
Detroit, Michigan, United States, 48201
United States, Minnesota
Pfizer Investigational Site
Minneapolis, Minnesota, United States, 55455
United States, Mississippi
Pfizer Investigational Site
Southaven, Mississippi, United States, 38671
Pfizer Investigational Site
Tupelo, Mississippi, United States, 38801
United States, Missouri
Pfizer Investigational Site
Columbia, Missouri, United States, 65203
Pfizer Investigational Site
Columbia, Missouri, United States, 65201
United States, Nebraska
Pfizer Investigational Site
Omaha, Nebraska, United States, 68198-7680
United States, New York
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Bronx, New York, United States, 10466
Pfizer Investigational Site
New York, New York, United States, 10021
Pfizer Investigational Site
New York, New York, United States, 10022
United States, North Carolina
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Durham, North Carolina, United States, 27710
United States, Ohio
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Cleveland, Ohio, United States, 44195
United States, Oklahoma
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Norman, Oklahoma, United States, 73071
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Oklahoma City, Oklahoma, United States, 73109
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Oklahoma City, Oklahoma, United States, 73102
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Oklahoma City, Oklahoma, United States, 73120
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Oklahoma City, Oklahoma, United States, 73112
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Tulsa, Oklahoma, United States, 74104
Pfizer Investigational Site
Tulsa, Oklahoma, United States, 74136-1902
United States, Oregon
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Portland, Oregon, United States, 97227
Pfizer Investigational Site
Portland, Oregon, United States, 97210
United States, Pennsylvania
Pfizer Investigational Site
Hershey, Pennsylvania, United States, 17033-0850
United States, Tennessee
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Memphis, Tennessee, United States, 38104
Pfizer Investigational Site
Memphis, Tennessee, United States, 38120
United States, Texas
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Dallas, Texas, United States, 75246
United States, Utah
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84112
United States, Washington
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Seattle, Washington, United States, 98104
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Seattle, Washington, United States, 98124
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Seattle, Washington, United States, 98109
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Seattle, Washington, United States, 98122
United States, Wisconsin
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Madison, Wisconsin, United States, 53792
Argentina
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Buenos Aires, Argentina, C1426ANZ
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Buenos Aires, Argentina, C1034ACO
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Buenos Aires, Argentina, C1431FWO
Australia, New South Wales
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Randwick, New South Wales, Australia, 2031
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St Leonards, New South Wales, Australia, 2065
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Westmead, New South Wales, Australia, 2145
Australia, Queensland
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South Brisbane, Queensland, Australia, 4101
Australia, South Australia
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Elizabeth Vale, South Australia, Australia, 5112
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Woodville South, South Australia, Australia, 5011
Australia, Victoria
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East Melbourne, Victoria, Australia, 3002
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Heidelburg, Victoria, Australia, 3084
Australia, Western Australia
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Perth, Western Australia, Australia, 6000
Austria
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Innsbruck, Austria, 6020
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Wien, Austria, 1090
Belgium
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Bruxelles, Belgium, 1000
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Bruxelles, Belgium, 1200
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Gent, Belgium, 9000
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Leuven, Belgium, 3000
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Liege, Belgium, 4000
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Wilrijk, Belgium, 2610
Bosnia and Herzegovina
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Sarajevo, Bosnia and Herzegovina, 71000
Brazil
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Salvador, BA, Brazil, 41950-640
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Belo Horizonte, MG, Brazil, 30380-490
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Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
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Rio de Janeiro, RJ, Brazil, 20230-130
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Rio de Janeiro, RJ, Brazil, 20231-050
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Porto Alegre, RS, Brazil, 90610-000
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Jau, SP, Brazil, 17210-120
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Jaú, SP, Brazil, 17210-080
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Jaú, SP, Brazil, 17210-120
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São Paulo, SP, Brazil, 01308-050
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São Paulo, SP, Brazil, 01509-900
Pfizer Investigational Site
São Paulo, SP, Brazil, 05651-000
Bulgaria
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Sofia, Bulgaria, 1756
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Sofia, Bulgaria, 1504
Canada, Alberta
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Calgary, Alberta, Canada, T2N 4N2
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Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
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Kelowna, British Columbia, Canada, V1Y 5L3
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Vancouver, British Columbia, Canada, V5Z 4E6
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Victoria, British Columbia, Canada, V8R 6V5
Canada, Manitoba
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Winnipeg, Manitoba, Canada, R3E 0V9
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Winnnipeg, Manitoba, Canada, R2H 2A6
Canada, Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 2Y9
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Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
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London, Ontario, Canada, N6A 4L6
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Toronto, Ontario, Canada, M5G 2M9
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Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
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Montreal, Quebec, Canada, H3T 1E2
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Montreal, Quebec, Canada, H2L 4M1
Canada
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Quebec, Canada, G1R 2J6
Chile
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Santiago, RM, Chile
Colombia
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Bogotá, Cundinamarca, Colombia, 0000
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Cali, Colombia
Croatia
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Rijeka, Croatia, 51000
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Split, Croatia, 21000
Czech Republic
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Brno, Czech Republic, 656 53
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Hradec Kralove, Czech Republic, 500 05
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Praha 5, Czech Republic, 150 06
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Praha 8, Czech Republic, 180 00
Ecuador
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Guayaquil, Guayas, Ecuador
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Quito, Pichincha, Ecuador
Egypt
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Cairo, Egypt
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Giza, Egypt
Finland
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Turku, Finland, 20521
France
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Lyon, Cedex 08, France, 69008
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Saint Herblain, Cedex, France, 44805
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Strasbourg, Cedex, France, 67091
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Bordeaux, France, 33000
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Clermont Ferand, France, 63011
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Marseille, France, 13385
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Marseille Cedex 9, France, 13273
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Montpellier, France, 34298 cedex 05
Pfizer Investigational Site
Paris, France, 75908
Pfizer Investigational Site
Paris Cedex 13, France, 75651
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Reims, France, 51100
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Rennes, France, 35042
Pfizer Investigational Site
Tours, France, 37044
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Vandoeuvre les Nancy, France, 54511
Germany
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Aachen, Germany, 52074
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Berlin, Germany, 10117
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Dresden, Germany, 01307
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Essen, Germany, 45122
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Frankfurt, Germany, 60590
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Freiburg, Germany, 79106
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Hamburg, Germany, 20246
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Hannover, Germany, 30625
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Homburg/Saar, Germany, 66421
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Jena, Germany, 07740
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Kassel, Germany, 34125
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Muenchen, Germany, 81664
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Nuernberg, Germany, 90419
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Rostock, Germany, 18057
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Ulm, Germany, 89081
Greece
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Athens, Attiki, Greece, 115 22
Pfizer Investigational Site
Athens, Greece, 11528
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Patras, Greece, 26500
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Thessaloniki, Greece, 540 07
Hong Kong
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Hong Hong, Hong Kong
Hungary
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Budapest, Hungary, 1122
India
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New Delhi, Delhi, India, 110 029
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Pune, Maharashtra, India, 411 004
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Parel, Mumbai, India, 400 012
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Jaipur, Rajasthan, India, 302 004
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New Delhi, India, 110 085
Ireland
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Dublin, Ireland
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Dublin 24, Ireland
Israel
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Jerusalem, Israel
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Tel Hashomer, Israel, 52621
Italy
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Bergamo, Italy, 24128
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Brescia, Italy, 25123
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Cattolica (RN), Italy, 47841
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Cuneo, Italy, 12100
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Legnago, VR, Italy, 37045
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Modena, Italy, 41100
Pfizer Investigational Site
Napoli, Italy, 80131
Pfizer Investigational Site
Padova, Italy, 35128
Pfizer Investigational Site
Parma, Italy, 43100
Pfizer Investigational Site
Pavia, Italy, 27100
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Perugia, Italy, 06132
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Pordenone, Italy, 33170
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Rimini, Italy, 47900
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Roma, Italy, 00135
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Roma, Italy, 00152
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Roma, Italy, 00144
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Torino, Italy, 10126
Korea, Republic of
Pfizer Investigational Site
Seoul, Korea, Republic of, 120-753
Pfizer Investigational Site
Seoul, Korea, Republic of, 110-744
Lebanon
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Beirut, Lebanon
Malaysia
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Petaling Jaya, Selangor, Malaysia, 46050
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Kuala Lumpur, Malaysia, 59100
Mexico
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Mexico, DF, Mexico, 06720
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Mexico, DF, Mexico, 14000
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Toluca, Estado de Mexico, Mexico, 50180
Pfizer Investigational Site
Guadalajara, Jalisco, Mexico, 44240
Pfizer Investigational Site
Merida, Yucatan, Mexico, 97000
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Chihuahua, Mexico, 31000
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Puebla, Mexico, 72530
Netherlands
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Groningen, GR, Netherlands, 9713 GZ
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Amsterdam, NH, Netherlands, 1066 CX
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Amsterdam, Netherlands, 1081 HV
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Rotterdam, Netherlands, 3075 EA
Norway
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Oslo, Norway, 0310
Panama
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Ciudad de Panama, Panama
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Panama, Panama
Peru
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Lima, Peru, 11
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Lima, Peru, L13
Philippines
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Quezon City, Philippines
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Quezon City, Philippines, 1102
Poland
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Gdansk, Poland, 80-210
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Lodz, Poland, 93-509
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Poznan, Poland, 60-569
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Warszawa, Poland, 00-909
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Wroclaw, Poland, 50-556
Portugal
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Lisboa, Portugal, 1070-213
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Porto, Portugal, 4200-319
Romania
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Bucuresti, Romania, 022328
Pfizer Investigational Site
Cluj-Napoca, Romania, 400015
Russian Federation
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Obninsk, Kaluga region, Russian Federation, 249036
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Chelyabinsk, Russian Federation, 454087
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Moscow, Russian Federation, 115478
Serbia
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Belgrade, Serbia, 11000
Singapore
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Singapore, Singapore, 169610
Slovakia
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Bratislava, Slovakia, 83301
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Zilina, Slovakia, 012 07
Slovenia
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Ljubljana, Slovenia, 1000 Ljubljana
Spain
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Oviedo, Asturias, Spain, 33006
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L'hospitalet Del Llobregat, Barcelona, Spain, 08907
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Pamplona, Navarra, Spain, 31008
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Baracaldo, Vizcaya, Spain, 48903
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Barcelona, Spain, 08025
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Barcelona, Spain, 08035
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La Coruña, Spain, 15006
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Madrid, Spain, 28007
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Madrid, Spain, 28041
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Madrid, Spain, 28040
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Salamanca, Spain, 37007
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Sevilla, Spain, 41013
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Valencia, Spain, 46009
Sweden
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Göteborg, Sweden, 413 45
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Lund, Sweden, 221 85
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Stockholm, Sweden, 171 76
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Umeå, Sweden, 901 85
Switzerland
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Basel, Switzerland, CH-4056
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Bellinzona, Switzerland, CH-6500
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Bern, Switzerland, 3010
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Biel, Switzerland, 2500
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CH-4058 Basel, Switzerland
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CH-4101 Bruderholz, Switzerland
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CH-4410 Liesthal, Switzerland
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Chur, Switzerland, CH-7000
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Genève 14, Switzerland, CH-1211
Taiwan
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Taipei, Taiwan, 100
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Taipei, Taiwan, 112
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Taoyun, Taiwan, 333
Thailand
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Bangkok, Thailand, 10330
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Bangkok, Thailand, 10700
Turkey
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Istanbul, Capa, Turkey, 34390
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Istanbul, Cerrahpasa, Turkey, 34303
United Kingdom
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Whitchurch, Cardiff, United Kingdom, CF14 2TL
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London, Se1 9rt, United Kingdom
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Sutton, Surrey, United Kingdom, SM2 5PT
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Leeds, West Yorkshire, United Kingdom, LS9 7TF
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Belfast, United Kingdom, BT9 7AB
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Birmingham, United Kingdom, B15 2TH
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Birmingham, United Kingdom, B15 2TT
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Bristol, United Kingdom, BS2 8ED
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Cottingham, United Kingdom, HU16 5JQ
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Edinburgh, United Kingdom, EH4 2XU
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Guildford, United Kingdom, GU2 5XX
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London, United Kingdom, NW3 2Qg
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London, United Kingdom, SW3 6JJ
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London, United Kingdom, EC1A 7BE
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Manchester, United Kingdom, M20 4BX
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Northwood, United Kingdom, HA6 2RN
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Nottingham, United Kingdom, NG5 1PB
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Sheffield, United Kingdom, S10 2SJ
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Southampton, United Kingdom, SO16 6YD
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Swansea, United Kingdom, SA2 8QA
Venezuela
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Caracas, Distrito Capital, Venezuela, 1040
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Caracas, Estado Miranda, Venezuela, 1060
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00130897     History of Changes
Other Study ID Numbers: A6181037
Study First Received: August 14, 2005
Last Updated: March 8, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on July 29, 2014